NCT03178708

Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

The Implications of Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients as Regard Its Effect on the Duration of Wake up Test and Postoperative Opioid Consumption

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

During the surgical procedure of scoliosis correction, large surgery extent and long-lasting strong nociceptive stimulation lead to postoperative pain formation of greater intensity compared with other orthopedic interventions. In these patients, duration of postoperative symptoms is longer, and may lead to persistent pain formation due to developing neuroplastic changes in the central nervous system.

Detailed description

Instrumentation in correction operations for spinal deformities as vertebral fusion, congenital and traumatic scoliosis, carries a 0.5-5% risk of injuring the spinal cord during spinal surgery. These complications are generally results of complex factors such as direct effects of compression on the spinal cord, distraction, the effects of spinal ischemia or arterial hypotension. The purpose of the wake-up test is to monitor voluntary motor function of the lower limbs once the vertebrae have been instrumented and distracted. The depth of anesthesia is gradually lightened up to the point where patients are able to respond to verbal commands. As the voluntary movement of lower extremities is demonstrated, the depth of anesthesia is increased to complete the surgery.

Conditions

• Spinal Curvatures

Interventions

Type	Name	Description
DRUG	Group A amantadine sulfate	infusion solution for slowly intravenous application 3 hours preoperative
OTHER	Group B ringer lactate	infusion solution for intravenous application 3 hours preoperative

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2017-06-07
• Last updated: 2021-01-12

Locations

1 site across 1 country: Egypt